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We have revised our guidance on the regulation of bone marrow and peripheral blood stem cells (PBSC) donations where the donor is an adult lacking capacity or child without competence to consent.
Under the Human Tissue Act 2004, any potential donation of bone marrow or peripheral blood stem cells (PBSC) from adults who lack capacity to consent and children who lack competence to consent, must be assessed by an Accredited Assessor (AA) and a report submitted to the HTA for decision.
The HTA is responsible for assessing all donations of bone marrow or PBSC (these are cells found in the bloodstream which are able to develop into all of the different cell types in blood) from adults who lack capacity to consent and children who lack competence to consent.
The removal licence is one of the HTA's lesser used licence type, principally because the activity of removal is covered by many of our other licences. A removal licence can be applied for if you wish to only remove relevent material, rather than storing or processing it as well.
Procurement is defined as the processes by which tissues and cells are made available, including the physical act of removing tissue and the donor selection and evaluation.
Medical school staff are sometimes faced with the challenge of deciding whether the consent given by potential donors, often many years before their death, is valid if it contains colloquial terminology and not the specific terms stated in the Human Tissue Act 2004 (the HT Act).
Download these standards as a PDF.
The HTA licenses a number of activities relating to human tissue. We are also responsible for carrying out inspections to ensure licence conditions are being met. These activities are laid out in the Human Tissue Act and associated Regulations.
The activities licensed by the HTA are: